Commission Decision
of 15 May 2007
authorising the placing on the market of oil enriched with phytosterols/phytostanols as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document number C(2007) 2073)
(Only the English text is authentic)
(2007/343/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, and in particular Article 7 thereof,
OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
Whereas:
(1) On 4 May 2005 the company Enzymotec made a request to the competent authorities of the Netherlands to place oil enriched with phytosterols/phytostanols on the market as a novel food or a novel food ingredient.
(2) On 23 May 2006 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that the oil enriched with phytosterols is safe for human consumption.
(3) The Commission forwarded the initial assessment report to all Member States on 29 May 2006.
(4) Within the sixty day-period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision.
(5) The objections raised concerned issues of risk management rather than risk assessment issues, therefore there was no need to consult the European Food Safety Authority (EFSA).
(6) The authorisation of oil enriched with phytosterols/phytostanols should only cover use in foods where the addition of phytosterols/phytostanols is authorised. The rules concerning the presentation and the labelling of foods with added phytosterols/phytostanols apply.
(7) Commission Regulation (EC) No 608/2004 of 31 March 2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters ensures that consumers receive the information necessary in order to avoid excessive intake of added phytosterols/phytostanols.
OJ L 97, 1.4.2004, p. 44.
(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION: